Introduction: The FDA recently approved three intragastric balloon (IGB) devices, ReShape, ORBERA™, and Obalon for treatment of obesity. Given the high cost, complication risk, and invasiveness of bariatric surgery, IGB treatment may present a safer and lower cost option for weight reduction. IGBs are generally placed in the stomach endoscopically for up to 6 months to reduce gastric capacity, enhance feelings of fullness, and induce weight loss. The mechanism of action likely involves stimulation of gastric mechanoreceptors triggering short-acting vagal signals to brain regions implicated in satiety. Balloon efficacy may be influenced by balloon volume, patient gastric capacity, and treatment duration.
Methods: This review focused on eight recent (2006-present) randomized controlled trials (RCTs) comparing percentage total body weight loss (%TBWL) between IGB and control groups including three reviewed by the FDA. %TBWL based on the reviewed studies was also compared with bariatric surgery and pharmacotherapy.
Results: Of the eight IGB studies, five had balloon treatment duration of 6 months. Efficacy at 6 months, based on a pooled weighted-mean %TBWL, was 9.7%, and the control-subtracted %TBWL was 5.6%. When one study without SDs was removed, the weighted mean %TBWL was 9.3 ± 5.7% SD, and control-subtracted %TBWL was 5.5 ± 7.8%, which was statistically greater than controls. IGB showed lower efficacy than bariatric surgery (median weight loss of 27% for Rouen-Y gastric bypass (RYGB). The control-subtracted %TBWL over 6 months of 5.5-5.6% is less than the most efficacious FDA-approved weight loss drug, Qsymia. At the recommended dose, Qsymia has a placebo-subtracted %TBWL at 6 months of approximately 6.6%. The weighted mean reported incidence of serious adverse events (SAEs) in the IGB group across all eight studies was 10.5%. Only six of the eight reviewed studies reported adverse events (AEs) in the IGB group, with a pooled reported incidence of 28.2%. Recently, the FDA reported new AEs including acute pancreatitis with ReShape and ORBERA™.
Conclusion: Based on the available evidence, it is unlikely that IGB use will supplant other forms of obesity treatment. The estimated cost of endoscopic balloon implantation and retrieval is US $8,150. Collectively, a relatively small control-subtracted %TBWL and the potential for serious complications makes IGB unlikely to become widely adopted. Given the recent FDA warning, IGB longevity on the market is questionable.
Keywords: Bariatric surgery; Endoscopy; Gastric capacity; Gastric distension; Obesity; Obesity treatment; Qsymia; Weight loss.